Is your user centered research and design company following the federal regulations pertaining to the use of human participants? If you're not, this recent story about a group of Cold War veterans filing a suit against the federal government should be a wakeup call. The regulations pertain to behavioral and social science research, as well as biomedical research, and what you don't know about them can hurt you and your chances of being funded in the future.Six decades ago members of the military volunteered for experiments on "nerve agents, biological weapons and mind-control techniques", conducted by branches of the Department of Defense. They are now experiencing health issues, and are now sueing the government for failing to inform them about the nature of these experiments, and for failing to obtain their consent to participate.
Following numerous tragic incidents like these, in 1974 the National Research Act was signed into law and a Commission was formed to establish ethical principles guiding research involving human participants.
The Belmont Report summarizes the principles established by this law, which fall into the basic categories of Respect for Persons, Beneficiance, and Justice.
Respect for Persons means that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The concept of Beneficiance means that human subject should not be harmed, and further should serve to benefit from the research in which they participate. The principle of Justice suggests that all persons should be treated equally in receiving benefits or burdens from research participation.
According to the Code of Federal Regulations, Title 45, Part 46 (Protection of Human Subjects), any research conducted or supported by any Federal Department or Agency must comply with certain requirements for procedures, review, and oversight.
The regulation defines the term "research", and identifies what populations of individuals are protected, and those that are considered vulnerable in a research setting. The makeup and functions of an Institutional Review Board (IRB) are defined, and criteria by which an IRB will evaluate prospective research plans involving human subjects. Required elements of an informed consent form are listed, as are the rules governing the use of vulnerable populations such as pregnant women, minors, prisoners and the disabled.
Any entity wishing to conduct human research must apply for and hold an Assurance of Compliance, which is an official legal written commitment by an institution (private or public entity) made to the Federal Government to comply with the Federal regulations while conducting research with human participants. It outlines the procedures and policies in place with the research organization that will enable it to comply with federal regulations, and designates the Institutional Review Board that will oversee research proposals.
While you might think this doesn't apply to you since your work doesn't involve medical procedures, these regulations apply to behavioral studies as well. An IRB reviewing your usability study will be interested in how you recruit your participants, whether they belong to a vulnerable population (e.g. soldiers assigned to participate in your DoD study), how you explain what will happen to them in your study and solicit their consent to participate (and to be photographed or videotaped), the compensation, risks, and benefits given to your participants, and how you protect their anonymity. An IRB can review your plans and determine whether they fall into a low-risk category and are potentially exempt or eligible for expedited review.
Your ability to work efficiently and stay within the law while conducting research for a client is greatly enhanced by familiarization with these laws and revivew processes. Minor differences in a test plan can mean months less review time, and fewer hours spent in painful reviews.
We'll cover some of the key considerations for obtaining study approval in future posts.
Dr. Lakinsmith is a senior scientist with Monterey Technologies, Inc., and has performed in a technical leadership role in a number of major commercial and government human engineering projects. She has applied user-centered principles and processes to the design and evaluation of both traditional and intelligent user interfaces on devices from screen-based telephones to critical cockpit systems.
No comments:
Post a Comment